GI Genius
K-Number: K211951 · 2021-07-23
Decision Date2021-07-23
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
GI Genius is a medical device manufactured by Cosmo Artificial Intelligence - Ai, Ltd.. It received FDA 510(k) clearance on 2021-07-23 under approval number K211951. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GI Genius?
GI Genius is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K211951.
When was GI Genius approved by the FDA?
GI Genius received FDA 510(k) clearance on 2021-07-23, under approval number K211951.
What company makes GI Genius?
GI Genius is manufactured by Cosmo Artificial Intelligence - Ai, Ltd..
What is the FDA product code for GI Genius?
The FDA product code for GI Genius is QNP.
Other Devices by Cosmo Artificial Intelligence - Ai, Ltd.
DEN200055GI Genius
K231143GI Genius System 100 and GI Genius System 200
K241887GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
K233964GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)
Related Devices (Code: QNP)
K211326EndoScreenerChengdu Wision Medical Device Co., Ltd.
DEN200055GI GeniusCosmo Artificial Intelligence - Ai, Ltd.
K213686SKOUT SoftwareIterative Scopes, Inc.
K230751EW10-EC02 Endoscopy Support ProgramFujifilm Corporation
K223473ME-APDS; MAGENTIQ-COLOMagentiq Eye, Ltd.
K231143GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.